Predictive Hemodynamic Monitoring During Elective Cesarean Section

NCT06729827 | Not Yet Recruiting

• 1 other identifier: 5508
• Study Type: interventional
• Target: 102
• Locations: 0 countries
• Sites: N/A

Brief Summary

Single shot spinal anesthesia (SA) is the most commonly used technique for Caesarean section (CS) . SA is associated with maternal hypotension (Post Spinal Hypotension - PSH) often accompanied by nausea, vomiting, bradycardia and fetal acidosis. Preventive administration of vasopressors is widely used to counterbalance hypotension. Routine prophylactic infusion of phenilephrine and norepinephrine raises concerns for unnecessary treatment, reactive hypertension, baroreceptor-mediated bradycardia, and effects on fetal acidosis. Non-invasive continuous measurement of arterial pressure using a finger cuff is well established. Hypotension Prediction Index - HPI is an algorithm that could predict the onset of hypotension in working on invasive and non-invasive arterial waveform signal. The aim of this prospective randomized study is to compare the amount of PSH during elective caesarean section among two groups of patients receiving standard intermittent hemodynamic monitoring versus continuous ClearSight-HPI monitoring. The primary hypothesis is that hemodynamic management HPI-guided reduces the incidence, entity and duration of post-spinal hypotension, defined as mean arterial pressure (MAP) lower than 65 mmHg lasting more than one minute. Our secondary aim was to study the impact of maternal PSH during CS on foetal outcome evaluated by comparing neonatal Apgar scores at 1 and 5 minutes after birth, and umbilical cord arterial and venous pH in the two groups.

Conditions

Pregnancy Related; Cesarean Section Complications; Hypotension on Induction; Anesthesia Complication

Keywords

Spinal induced hypotension; cesarean section; hypotension nprediction

Outcome Measures

Primary Outcomes (1)

• AUC-MAP<65 mmHg 20 min

  Area under the curve (AUC) for Mean Arterial Pressure \< 65 mmHg.

  In the first 20 min after Spinal Anesthesia

Secondary Outcomes (3)

• Fetal wellbeing - 1

  At the birth of the fetus

• Fetal wellbeing - 2

  After 5 min from the birth of the fetus

• TWA-MAP < 65 mmHg

  At the end of the surgery.

Other Outcomes (2)

• Total fluids and vasopressor use

  At the end of the surgery.

• Maternal side effects

  At 2 hours after surgery.

Study Arms (2)

Predictive monitoring - HPI

EXPERIMENTAL

In the HPI-group the patients will be treated with a bolus of norepinephrine 5 mcg each time that HPI is 85 or higher.

Device: Hypotension prediction Index - HPI

Control group

NO INTERVENTION

In the control group a rescue bolus of norepinephrine 5 mcg will be administered by the anesthesia care provider whenever MAP decreases below 65 mmHg.

Interventions

Hypotension prediction Index - HPI DEVICE

Patients in the HPI group, in addition to standard monitoring, will have hemodynamic monitoring using HemoSphere (Edwards Lifesciences, Irvine, CA) with ClearSight non-invasive hemodynamic monitoring and with the HPI software enabled. The patients will be treated with a bolus of norepinephrine 5 mcg each time that HPI is 85 or higher.

Predictive monitoring - HPI

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Full term pregnancy
• Elective cesarean section under spinal anesthesia
• Age \> 18 years

You may not qualify if:

• refusal to participate to the study
• preeclampsia
• cardiovascular diseases
• neuromuscular disease;
• emergent or urgent cesarean delivery;
• coagulopathies;
• contraindications to spinal anesthesia.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Related Publications (22)

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Central Study Contacts

Luciano Frassanito, MD

CONTACT

00393475256158; luciano.frassanito@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: December 7, 2024
• First Posted: December 11, 2024
• Study Start: January 1, 2025
• Primary Completion: March 1, 2025
• Study Completion: May 1, 2025
• Last Updated: December 11, 2024

Record last verified: 2024-12